Quality Assurance Architect Consultant

Job Description

Due to the substantial increase in our business, we are currently looking for a Quality Assurance Specialist to join our team of consultants.

• Supports creation and implementation of the aseptic operator training program for the site
• Creation and update of procedures and risk assessments
• Ensures adherence to global procedures and standards
• Creation of SOPs in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
• Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
• Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)

Required Profile

• Minimum 4 years of experience in the industry